Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study.

IF 5.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-05-04 DOI:10.1093/ehjcvp/pvad100

Marie Hauguel-Moreau, Paul Guedeney, Claire Dauphin, Vincent Auffret, Eloi Marijon, Philippe Aldebert, Jean-Michel Clerc, Farzin Beygui, Meyer Elbaz, Wissam Abi Khalil, Antoine Da Costa, Jean-Christophe Macia, Simon Elhadad, Guillaume Cayla, Delphine Brugier, Johanne Silvain, Nadjib Hammoudi, Guillaume Duthoit, Eric Vicaut, Gilles Montalescot

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引用次数: 0

Abstract

Introduction: Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown.

Methods/design: The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150 mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150 mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30 s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study.

Conclusion: AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure.

Clinical trial registration: NCT05213104 (clinicaltrials.gov).

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弗来凯尼预防卵圆孔关闭术后房性心律失常随机 AFLOAT 研究的原理和设计。

导言：房性心律失常是卵圆孔（PFO）关闭术最常见的并发症。PFO 关闭术后房性心律失常的实际发生率以及这种并发症是否可以预防尚不清楚：弗来凯尼降低卵圆孔关闭术后房颤或心动过速风险的评估（AFLOAT）试验是一项前瞻性、全国性、多中心、随机、开放标签、优越性试验，对所有终点进行盲法评估（PROBE 设计）。共有 186 名患者在 PFO 关闭后立即按 1:1:1 的比例随机接受弗来凯尼（每天 150 毫克，单次缓释剂量）治疗 6 个月（第 1 组）、弗来凯尼（每天 150 毫克，单次缓释剂量）治疗 3 个月（第 2 组）或不接受额外治疗（标准护理）6 个月（第 3 组）。主要终点是在使用插入式心电监护仪进行长期监测时，记录到 PFO 关闭后 3 个月内至少有一次症状性或无症状性房性心律失常发作（≥30 秒）的患者比例。研究的次要目标是分析治疗 3 个月与 6 个月相比是否足够：AFLOAT 是首个验证口服氟卡尼短期治疗可预防 PFO 关闭术后新发房性心律失常这一假设的试验。临床试验注册：NCT05213104（clinicaltrials.gov）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine

CiteScore

10.10

自引率

14.10%

发文量

期刊介绍： The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.